Why it was recalled
Presence of Particulate Matter.
Product description
Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 mL Multiple-Dose Vial, Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977. NDC: 42023-206-01
Lot numbers, UPCs & expiration codes
Lot#: 57014; Exp, 04/30/2024
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0429-2024
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Mar 4, 2024
- FDA report date
- Apr 3, 2024
- Quantity
- 466 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Par Sterile Products LLC
Original FDA data
Every field from FDA enforcement report D-0429-2024, exactly as published.
Show all FDA fields
- City
- Rochester
- State
- MI
- Status
- Ongoing
- Country
- United States
- Event ID
- 94166
- Address
- 870 Parkdale Rd
- Code information
- Lot#: 57014; Exp, 04/30/2024
- Postal code
- 48307-1740
- Report date
- Apr 3, 2024
- Product type
- Drugs
- Recall number
- D-0429-2024
- Classification
- Class I
- Recalling firm
- Par Sterile Products LLC
- Product quantity
- 466 vials
- Reason for recall
- Presence of Particulate Matter.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 mL Multiple-Dose Vial, Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977. NDC: 42023-206-01
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Mar 4, 2024
- Initial firm notification
- Letter
- Center classification date
- Mar 28, 2024